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Wednesday, July 27, 2011

HHS Moves to Review Outdated Lifetime Gay Blood Donor Deferral

artwork courtesy of www.ilga.org

Gay Men's Health Crisis (GMHC) and the World Federation of Hemophilia laud the U.S. Department of Health and Human Services (HHS) for outlining concrete steps toward review of the Food and Drug Administration's (FDA) permanent deferral on blood donation by gay and bisexual men. In a question-and-answer document, HHS described four areas of necessary study to allow a further review of the existing policy, and implementation of the June 2010 recommendations from the Advisory Committee on Blood Safety and Availability (ACBSA). These areas include:

How the risk of blood transmissible diseases in the current donor population relate to the risk factors in donors;

The root cause of quarantine release errors (QRE), the accidental release of blood not cleared for use that potentially put the blood supply at risk;

If potential donors correctly understand the current questionnaire and if men who have sex with men (MSM) would comply with modified deferral criteria; and

If alternative screening strategy (e.g. pre- and/or post-qualifying donation infectious disease testing) for MSM (and potentially other high-risk donors) would assure blood safety while enabling data collection that could demonstrate safe blood collection from a subset of MSM or other currently deferred donors.

"We are pleased to see that the federal government has taken critical steps to review outdated blood donation policies," said Nathan Schaefer, Director of Public Policy at GMHC. "As this research agenda is pursued, GMHC will continue educating the public about the negative consequences of current blood donation policies, and advocating for revised policies that would allow low-risk gay men to donate blood and maintain the highest standard of blood safety."

"The safety of the nation's blood supply is of paramount importance to all Americans," said Mark Skinner, President of the World Federation of Hemophilia. "We are encouraged by the Secretary's proposed research agenda. The knowledge gained will allow for a thoughtful scientific review of the suboptimal aspects of the donor deferral policy. We look forward to the Secretary engaging both donors and patients in the research process."

In February 2010, GMHC released a comprehensive report titled "A Drive For Change: Reforming U.S. Blood Donation Policies," which details the FDA's current blood donation guidelines and provides recommendations for alternative guidelines that emphasize behavior-based deferrals. In June 2010, GMHC provided testimony at the ACBSA meeting held to review the MSM policy. GMHC has long advocated for consistently applied standards of rigorous, scientifically-based blood safety, contributing to an increased pool of blood donors.

In June 2010, Mark Skinner spoke on behalf of the American Plasma Users Coalition (A-PLUS) at the ACBSA meeting held to review the MSM policy. A-PLUS is a coalition of national patient organizations created to address the unique needs of over 125,000 patients with rare diseases that use life-saving plasma protein therapies and are dependent on blood plasma therapies to lead healthy. A-PLUS has acknowledged that the scientific basis for the permanent deferral requires review, and previously indicated that there are a number of factors which should be fully evaluated before making a revision to the policy. Such evaluation and research could lead to a policy revision that maintains or enhances the safety of blood and blood products.